Status:
RECRUITING
A Study of GZR4 Injection at Different Injection Sites
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Healthy Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4...
Eligibility Criteria
Inclusion
- 1\. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- 2\. A Male adult subjects aged 18-55 years old.
- 3\. Body mass index (BMI) between 19.0-24.0 kg/m2
Exclusion
- 1\. Known or suspected hypersensitivity to investigational medical product(s) or related products.
- 2\. Participation in a clinical study of another study drug within 3 months prior to randomization.
- 3\. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
- 4\. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
- 5\. More than 14 units of alcohol per week within 3 months prior to randomization
- 6\. Smoking more than 5 cigarettes per day within 3 months prior to randomization
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06548906
Start Date
May 8 2024
End Date
August 31 2024
Last Update
August 12 2024
Active Locations (1)
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1
Study Site
Beijing, China